Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）

Valvular Heart Disease Clinical Trial

Official title:

A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797820
• Other study ID #: SAHZJU CT012
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area=1.5cm2, or maximal jet velocity =3.0m/sec, or mean pressure gradient=20mmHg

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.

2. Patients in critical condition may be die in one year.

3. Patients have been enrolled in this study.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• Our study type is observational
Our study type is observational

Locations

Country	Name	City	State
China	Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (10)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Jinhua Central Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo No. 1 Hospital, Second Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, The Central Hospital of Lishui City, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

References & Publications (1)

Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement	time from enrolled to first occurrence of any of the components of the composite outcome	one year
Secondary	Hospitalization for heart failure	time from enrolled to first occurrence of the outcome	one year
Secondary	Surgical or transcatheter aortic valve replacement	time from enrolled to first occurrence of the outcome	one year
Secondary	Cardiovascular death	time from enrolled to first occurrence of the outcome	one year

External Links

•   A hospital-based survey of patients with severe valvular heart disease in China